Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates

Not Applicable

Completed

• Conditions: Catheter-Associated Urinary Tract Infection
• Interventions: Device: ReadyCleanse Cloths

• Registration Number: NCT03645967
• Lead Sponsor: Medline Industries

Brief Summary

Superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.

Detailed Description

A superiority study evaluating the efficacy of a complete cleansing system composed of 5 prepackaged, moistened cloths with a standardized cleaning method compared to the previous standard-of-care for catheter care and maintenance. The primary objective is to investigate if the implementation of prepackaged cleansing cloths with a standardized cleaning protocol for all indwelling urinary catheter (IUC) care and maintenance provides a reduction in CAUTIs. The ReadyCleanse complete cleansing system will replace the previous standard-of-care. The ReadyCleanse intervention will be compared to the previous standard-of-care retrospectively.

Study Timeline

• Study First Submitted: 2018-07-26
• Study Start: 2018-08-01
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-26
• Status Verified: 2021-10
• Results First Submitted: 2021-10-22
• Results First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9891

Inclusion Criteria

• any adult patient who requires an IUC to be placed during admission to one of the four study hospitals

Exclusion Criteria

• patients <18 years of age
• patients whose entire hospital stay occurs in: pediatric unit, psychiatric unit, labor & delivery or postpartum units, and emergency room

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReadyCleanse for IUC	ReadyCleanse Cloths	ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used.

Primary Outcome Measures

Name	Time	Method
Infections Per 1,000 (CAUTI) Days	16 months	Incidence Rate for CAUTIs per 1,000 Catheter days

Secondary Outcome Measures

Name	Time	Method
Number of "Health Care Providers Responding to Health Care Provider Feedback Survey	Begins 3 months after start date. Time to take survey is approximately 10 minutes.	Healthcare provider feedback survey will be delivered to all staff that have utilized the ReadyCleanse cloths for indwelling urinary catheter care and maintenance. Purpose of the survey is to investigate healthcare provider preference and opinion of device.

Trial Locations

Locations (4)

NorthShore University HealthSystem - Highland Park; 🇺🇸 Highland Park, Illinois, United States

NorthShore University HealthSystem - Evanston; 🇺🇸 Evanston, Illinois, United States

NorthShore University HealthSystem - Glenbrook; 🇺🇸 Glenview, Illinois, United States

NorthShore University HealthSystem - Skokie; 🇺🇸 Skokie, Illinois, United States